FDA News

The FDA has approved nirogacestat as a treatment for adults with progressing desmoid tumors based off findings from the phase 3 DeFi trial.

The FDA has expanded the indication for enzalutamide to include patients with high-risk nonmetastatic castration-sensitive prostate cancer.

The FDA has approved capivasertib plus fulvestrant to treat patients with locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations.

The FDA has approved pembrolizumab plus chemotherapy to treat adults with locally advanced or metastatic, HER2-negative gastric cancers.

Repotrectinib is now available to treat adults with advanced or metastatic non-small cell lung cancer that harbors a ROS1 fusion.

The PD-L1 IHC 22C3 pharmDx diagnostic tool will help identify patients with gastric or gastroesophageal junction adenocarcinoma whose disease expresses PD-L1 and who are thereby eligible for pembrolizumab.

The FDA has restricted the indication for gastric cancer to only include patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.

Lisocabtagene maraleucel is under consideration as a potential treatment option for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA has approved fruquintinib to treat adults with metastatic colorectal cancer.

The FDA has approved toripalimab, with cisplatin and gemcitabine, and as a monotherapy, to treat adults with nasopharyngeal carcinoma.

Ivosidenib, a targeted therapy, has been approved for patients with relapsed or refractory myelodysplastic syndromes and an IDH1 mutation.

The FDA has approved entrectinib to treat pediatric patients ages 1 month and older with NTRK-positive solid tumors.

The FDA has approved tests to identify patients with metastatic non–small cell lung cancer who are eligible for treatment with encorafenib plus binimetinib.

The FDA has granted priority view to osimertinib plus chemotherapy based on data from the phase 3 FLAURA2 trial.

The FDA has approved pembrolizumab with platinum-containing chemotherapy for patients with resectable non–small cell lung cancer, in both the neoadjuvant and adjuvant setting.

The FDA has approved adjuvant nivolumab to treat completely resected stage IIB/C melanoma.

The FDA has approved encorafenib plus binimetinib to treat adults with metastatic non-small cell lung cancer with a BRAF V600E mutation.

The approval of FoundationOne CDx as a companion diagnostic for selpercatinib seeks to broaden access to therapies for patients with RET fusion–positive solid tumors.

The FDA has granted marketing authorization to the Invitae Common Hereditary Cancers Panel, which can detect multiple genetic variants associated with hereditary cancers.

The FDA has granted priority review to odronextamab for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.

The FDA has approved bosutinib to treat pediatric patients with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia.

The FDA has granted belzutifan priority review designation based on data from the phase 3 LITESPARK-005 trial.

The FDA has approved momelotinib (Ojjaara) for the treatment of adult patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia.

The FDA has approved motixafortide in combination with filgrastim to mobilize hematopoietic stem cells in multiple myeloma transplantation, based on findings from the phase 3 GENESIS trial.

The FDA has approved luspatercept to treat anemia in patients with lower-risk myelodysplastic syndromes.

The FDA has granted enzalutamide priority review designation based on data from the phase 3 EMBARK trial.

The FDA has granted ivosidenib priority review designation based on data from a phase 1 trial.

FoundationOne CDx is a next-generation sequencing–based in vitro diagnostic device developed to detect substitutions, insertion, and deletion alterations using 1 tissue sample.